Will we finally have options to prevent posttransplantation HCV recurrence across the spectrum of genotypes?

Although current options for posttransplantation recurrence of genotype 1 and 4 HCV can achieve high SVRs, options with equivalent efficacy for posttransplantation recurrence of genotype 3 HCV are limited. At the 2015 European Association for the Study of the Liver (EASL) meeting, data from the phase III ALLY-1 study gave us a clear glimpse at an upcoming option for managing patients with genotype 3 HCV recurrence following orthotopic liver transplantation. The multicenter, open-label trial evaluated the investigational NS5A inhibitor daclatasvir in combination with sofosbuvir and ribavirin for 12 weeks in patients with advanced cirrhosis or posttransplantation HCV recurrence.

Eligible patients were ≥ 3 months posttransplantation with no evidence of rejection at enrollment. Of importance, any immunosuppressive regimen was allowed. The overall SVR12 rate in this posttransplantation population of 53 patients was 94%; when broken down by patient factors, 97% of patients with genotype 1a, 90% of those with genotype 1b, and 91% of those with genotype 3 HCV infection achieved SVR12. There was even 1 patient with genotype 6 HCV infection enrolled, who also achieved SVR12.

The regimen was well tolerated, with the few serious adverse events considered unrelated to treatment.

HCV Reading: Pharmaceutical companies name their price tag for drugs and that’s that.

In case you missed it, an editorial was published over at Forbes yesterday about the high rise in specialty drug spending with a proposed new pricing model, written by Bernard J. Tyson, chief executive at Kaiser.

According to the article by 2020 drug spending could reach $400 billion, up from $87 billion in 2012, citing the cost of new HCV drugs as one example. Sadly, the high price tag left far too many patients out in the cold, with payers rationing out the new drugs to only the sickest patients, Tyson writes;

Last year, new life-changing treatments for hepatitis C became available. These treatments are truly remarkable, and very, very expensive. The prices were so high that some professional organizations recommended treatment only for the very sickest patients, an unthinkable step for many in the industry.

In an integrated system like Kaiser Permanente we see the entire health care dollar, so we can assess the outcomes of new drugs and related costs over time. To help us further assess the value of these drugs we have put in place a system to track the efficacy and real world impact of treatments. I expect to use that data, which is non-patient specific, as part of the conversation with my peers in the pharmaceutical industry....

Of InterestAddressing the Restricted Use of DAA therapies
Posted on July 6, 2015
Results of a new US cost effectiveness study indicate that effective direct acting antiviral (DAA) therapies should be not be restricted to only those HCV-infected patients with advanced fibrosis. Authors note that as a society, we have an opportunity to eliminate hepatitis C by taking appropriate and timely steps, and we should be willing to pay for the current HCV therapies by providing additional resources and giving hepatitis C the attention it deserves.

Thursday, July 30, 2015

There are about 3 million living with hepatitis C in the U.S., many of whom haven’t been diagnosed, according to the Centers for Disease Control and Prevention. Gilead’s drugs, and a competing medicine from AbbVie Inc., cure more than 90 percent of those treated. While doctors are seeing patients as fast as they can, they’ve administered the drugs to only a tiny fraction of the patient population. So far this year, Gilead’s drugs have treated about 130,000 in the U.S., and AbbVie’s about 10,000, according to the companies and data compiled by Bloomberg.

Many More Left
That leaves more than 2 million, and possibly many more if the CDC’s estimates are too low. When Gilead talks to doctors, “all of them tell us that they have many patients in the queue, if you like, waiting for treatment,” Paul Carter, Gilead’s executive vice president of commercial operations, said Tuesday on a conference call.

Gilead Sciences announced second quarter financial results and showed an increase of $1.7 billion for overall product sales and an increase of $1.6 billion in antiviral product sales since the second quarter of 2014, due in large part to the sales of Harvoni, according to a press release from Gilead.

According to the financial report, total product sales for the second quarter of 2015 were $8.1 billion, an increase of $1.7 billion from $6.4 billion in sales of the 2014 second quarter. The sales in the U.S. alone increased to $5.6 billion from $4.8 billion in the second quarter of 2014 and product sales in Europe increased from $1.3 billion to $2 billion.

As World Hepatitis Day draws to a close, Bristol-Myers Squibb has hit back at NICE's decision to restrict use of its new hepatitis C treatment Daklinza (daclatasvir) to a sub-population of patients.

In draft guidance released today, NICE has said that the NS5A replication complex inhibitor, in combination with other treatments, is recommended for HCV genotypes 1 and 4 who have significant fibrosis (liver scarring) without cirrhosis, if that patient has been previously treated with the injectable treatment interferon, or is ineligible or intolerant to interferon..

The National Institute for Clinical Excellence (NICE) has today issued appraisal consultation documents for three new hepatitis C therapies; ledipasvir-sofosbuvir (Harvoni), daclatasvir (Daklinza, and ombitasvir/paritaprevir/ritonavir (with or without dasabuvir).

A summary of the recommendations, which at this stage are preliminary, are below:

Ledipasvir-sofosbuvir

Genotype 1
Recommended for use on treatment-naïve patients without cirrhosis for 8 weeks.
Recommended for use on treatment-experienced patients without cirrhosis for 12 weeks.
Recommended for use on treatment-naïve patients with compensated cirrhosis for 12 weeks.
Recommended for use on treatment-experienced patients with compensated cirrhosis for 12 weeks if a number of criteria (related to platelet count and previous history) are met.

Genotype 4
Recommended for use on treatment-naïve patients without cirrhosis for 12 weeks.
Recommended for use on treatment-naïve patients with compensated cirrhosis for 12 weeks.
Recommended for use on treatment-experienced patients with compensated cirrhosis for 12 weeks if a number of criteria (related to platelet count and previous history) are met.

Daclatasvir
Recommended for use on genotype 1 and 4 treatment-experienced patients and patients who are interferon-ineligible or intolerant if the patient has significant fibrosis (METAVIR fibrosis stage F3-F4).

Genotype 1b
Recommended for use on treatment-naïve patients without cirrhosis for 12 weeks.
Recommended for use on treatment-experienced patients without cirrhosis for 12 weeks.
Recommended for use (with ribavirin) on treatment-naïve patients with compensated cirrhosis for 12 weeks.
Recommended for use (with ribavirin) on treatment-experienced patients with compensated cirrhosis for 12 weeks.

Genotype 1a
Recommended for use (with ribavirin) on treatment-naïve patients without compensated cirrhosis for 12 weeks.
Recommended for use (with ribavirin) on treatment-experienced patients without compensated cirrhosis for 12 weeks.

A consultation process will now occur whereby interested parties, including The Hepatitis C Trust, will provide comments on these recommendations. All comments must be submitted by 19th August, with further Appraisal Committee meetings being held on 3rd September. Final Appraisal Determination documents (which represent the final NICE recommendations) will then be published within 6 weeks of this meeting.

We would like to assure all patients that The Hepatitis C Trust will continue to argue for access to new treatments to be as wide as possible, and this will be reflected in our response to these preliminary recommendations.

Tuesday, July 28, 2015

Merck Announces U.S. Food and Drug Administration Acceptance of New Drug Application for Grazoprevir/Elbasvir, an Investigational Therapy for Treatment of Chronic Hepatitis C Genotypes 1, 4 and 6 Infection

Company Granted FDA Priority Review with Target Action Date of January 28, 2016

Tuesday, July 28, 2015 6:30 am EDT

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application for grazoprevir/elbasvir (100mg/50mg), an investigational, once-daily, single-tablet combination therapy for the treatment of adult patients infected with chronic hepatitis C virus (HCV) genotypes (GT) 1, 4 or 6.1 The FDA granted Priority Review for grazoprevir/elbasvir (100mg/50mg), with a Prescription Drug User Fee Act (PDUFA) action date of January 28, 2016.

“The U.S. FDA’s Priority Review designation for grazoprevir/elbasvir underscores how innovative treatment approaches for chronic hepatitis C are still needed for many patient populations,” said Dr. Roy Baynes, senior vice president of clinical development, Merck Research Laboratories. “Our clinical data for grazoprevir/elbasvir in broad and diverse patient populations with chronic hepatitis C are very encouraging, and we look forward to continuing our dialogue with the FDA to bring this novel combination medicine to the appropriate patients with chronic hepatitis C.”

The New Drug Application for grazoprevir/elbasvir (100mg/50mg) is based in part upon data from the pivotal C-EDGE clinical trials program, as well as the C-SURFER and C-SALVAGE trials. Data from these trials were previously presented at The International Liver Conference 2015™. Collectively, these trials evaluated treatment regimens of grazoprevir/elbasvir (100mg/50mg), with or without ribavirin, in multiple genotypes (GT1, 4 and 6) including patient populations who were previously treated, and those with cirrhosis or certain co-morbidities (e.g., HIV/HCV co-infection, chronic kidney disease stages 4 and 5).

In April 2015, the FDA granted Breakthrough Therapy designation status for grazoprevir/elbasvir for the treatment of patients infected with chronic HCV GT1 with end stage renal disease on hemodialysis, and Breakthrough Therapy designation status for grazoprevir/elbasvir for the treatment of patients infected with chronic HCV GT4. Breakthrough Therapy designation is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

About Merck

Today’s Merck is a global health care leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

Forward-Looking Statement of Merck & Co. Inc., Kenilworth, NJ, USA

This news release of Merck & Co., Inc., Kenilworth, NJ, USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include, but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation in the United States and internationally; global trends toward healthcare cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2014 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

A three-month highway spending bill scheduled for a vote Wednesday in the House includes nearly $3.4 billion to fill a budget hole that the Department of Veterans Affairs claims would force it to close hospitals and clinics nationwide. Lawmakers from both parties said the spending was needed even as they complained about the VA's failure to anticipate the problem.

An amendment sponsored by Rep. Jeff Miller, R-Fla., chairman of the House Veterans Affairs Committee, would allow VA to use $3.35 billion from the new Veterans Choice program to pay for private health care for veterans from May 1 to Oct. 1.

Under the amendment, the VA could use up to $500 million from the Choice program to cover costs of treating the deadly hepatitis C virus.

On World Hepatitis Day, Dr Marcus Dorner of the Department of Medicine, describes the current state of viral hepatitis research and treatment options.

Research in the field of viral hepatitis, especially on hepatitis C virus (HCV) infection has made incredible progress in recent years. This has lead to the development of an enormous number of novel therapies promising a cure for most of the over 130 million infected people worldwide (WHO 2015).

Up until recently treatment meant one year of injections with interferon, which lead to significant side effects and did by no means guarantee cure of the disease. With new therapies being approved constantly, people chronically infected with HCV can now look forward to over 90% treatment success rates, with therapies shortening in duration and virtually absent of side effects (1, 7). This has clearly changed the landscape for both the treatment of infected patients and research on HCV.

During the past few years, the focus of research and clinical virology has shifted from drug development to the identification of infected people and the optimisation of novel combination treatments. Even though the official number of people with HCV ranges from 130-170 million, there are likely many people who do not know they are infected. The slow progression of HCV together with the nature of its transmission has lead to a large number of people living with infection without knowledge of it.

For the longest time, the public has associated HCV infection with intravenous drug use and the sharing of needles; clearly contributing to the stigma associated with infection. This however is only one part of the equation. Prior to routine blood supply screening the majority of new infections could be attributed to blood transfusions, and in recent years the use of inadequately sterilized tattooing needles and dental equipment has lead to several instances of transmission of the virus. This, together with the fact that prolonged infection with HCV eventually leads to the development of liver cirrhosis and liver cancer, underlines the urgency of identifying all infected individuals and ultimately curing them.

But this is exactly the problem policy makers are facing at the moment. The efficacy and curative effects of new treatments over a relatively short period of time have in turn resulted in prices that make universal treatment prohibitively expensive. With costs as high as £120,000 for each treatment the total for treating the estimated 214,000 HCV-infected in the UK would exceed 25 billion pounds, or about a quarter of the total annual budget of the NHS (2-6). Even though pharmaceutical companies are already lowering the prices for treatments (such as the Gilead Global Access Programme) there is an urgent need for a protective vaccine, which still does not exist, as well as more economically viable treatment alternatives.

Despite the significant progress in fighting chronic liver disease associated with viral hepatitis, another member of this viral family has gone nearly unnoticed. Hepatitis B virus (HBV) shares a lot of its clinical symptoms with HCV and is also associated with the development of liver cancer. It has infected over 350 million people worldwide (WHO 2015) - over 180,000 of those in the UK (GOV.UK 2015).

Even though there is an effective vaccine available, millions of new HBV infections are reported each year. The good news for people infected is that funds allocated for viral hepatitis research will likely be re-allocated to focus on hepatitis B virus. It is however unlikely that the success story of HCV will repeat itself in the same time scale for HBV.

To date, many of the treatment options for HBV have been “borrowed” from HIV treatment, in that drugs affecting the HIV reverse transcriptase are also active in the hepatitis B virus. These treatments, although very effective in suppressing HBV replication do not constitute a cure for infection. Whenever treatment is interrupted hepatitis B virus starts replicating again. Even though in the last few years several new clinical trials were launched evaluating the efficacy of novel treatment options, a complete cure remains elusive.

It is important to keep in mind that, mainly due to the slow progression of viral hepatitis, the focus of the public is easily drawn to other infectious diseases with seemingly greater impact on public health. Globally however, the total number of people living with chronic liver disease associated with viral hepatitis is about 15 times the number of people living with HIV and the number of annual deaths are comparable to the number of people dying from seasonal influenza. These unimaginable numbers clearly mandate an even stronger effort to making effective and affordable vaccines and treatments available to everyone.

Both, hepatitis B and C virus only infect humans, making these pathogens perfect candidates for eradication; a goal that if accomplished would save countless lives in the future.

NASHVILLE – The Tennessee Department of Health is issuing a public health advisory urging residents to increase their awareness about Hepatitis C, a life-threatening disease spread by direct contact with blood from an infected person. The rate of acute Hepatitis C cases in Tennessee has more than tripled in the last seven years, and the steadily increasing number of cases may only represent “the tip of the iceberg” of the state’s Hepatitis-C epidemic, according to TDH Commissioner John Dreyzehner, MD, MPH.

“In addition to reported cases of acute Hepatitis C it is estimated that more than 100,000 Tennesseans may be living with chronic Hepatitis C and not know it,” Dreyzehner said. “Many people have Hepatitis C for years, not realizing it, while the viral infection slowly destroys their livers.”

There is no vaccine to prevent Hepatitis C, so efforts to avoid exposure to infected blood are most important in preventing the spread of the disease. Most of the increase in transmission of Hepatitis C in Tennessee is due to the sharing of contaminated needles and syringes among intravenous drug users who are abusing both legal and illegal pain medicines.

Once infected with Hepatitis C, some people may recover fully, but most, 70 to 85 percent, will develop long-term infection. Early symptoms of Hepatitis C infection can include fatigue, abdominal pain, itching and dark urine. Many people, however, are not aware they have the disease until the virus has already caused liver cancer or liver damage.

“We strongly encourage those who suspect they might be infected to seek testing as soon as possible,” Dreyzehner said. “Testing can be done by a private health care provider and in some county health departments. The Centers for Disease Control and Prevention recommends all individuals born from 1945 to 1965 be tested, as well as individuals of any age who have any specific risk factors, including a history of injection drug use or unsanitary tattooing or piercing. If chronic Hepatitis C infection is present, a doctor can recommend treatment options. The sooner an infection is identified and treatment started, the better a person’s chances are for recovery.”

The treatment for Hepatitis C is currently expensive and a person can later become re-infected. A recent CDC report shows Hepatitis C is the most common blood-borne infection in the United States, with approximately three million people living with the infection. That report, available online at www.cdc.gov/mmwR/pdf/wk/mm6417.pdf, includes information about a 364 percent increase in Hepatitis C in four Appalachian states, including Tennessee, between 2006 and 2012.

“The best way to prevent Hepatitis C infection is to avoid recreational use of pain medicines, to avoid injecting drugs, and to not let those you love become dependent on or inject pain medicines or other illicit drugs such as heroin and methamphetamines,” Dreyzehner said. “We must all work more aggressively to reduce Hepatitis C in our communities; left unchecked, it will destroy families and wreak havoc on communities.”

The mission of the Tennessee Department of Health is to protect, promote and improve the health and prosperity of people in Tennessee. TDH has facilities in all 95 counties and provides direct services for more than one in five Tennesseans annually as well as indirect services for everyone in the state, including emergency response to health threats, licensure of health professionals, regulation of health care facilities and inspection of food service establishments. Learn more about TDH services and programs at www.tn.gov/health.

Monday, July 27, 2015

Many Factors Determine Treatments in Hepatitis C Patients
Published on Jul 27, 2015
While genotype is one of the overriding factors in determining course of treatment for patients with hepatitis C there are other areas to consider as well. This can include other health conditions they are being treated for, potential drug use, and other medications they are taking as well.
Source - MD Magazine TV

Determining Genotype in Hepatitis C Determines Treatment Course
Published on Jul 27, 2015
Once a patient has tested positive for hepatitis C the question then becomes which of the six genotypes and sub-genotypes do they have. Answering that question will determine what the next steps in care will be.
Source - MD Magazine TV

Genotype 1 Hepatitis C is Common with Increasingly Effective Treatment
Published on Jul 27, 2015
In the United States the two most common forms of hepatitis C are genotypes 1 and 2. They are also becoming increasingly easy to treat though the medications can be expensive for some patients.
Source - MD Magazine TV

Gilead Sciences is an American pharmaceutical company driven by unquenchable greed. The company is causing hundreds of thousands of Americans with Hepatitis C to suffer unnecessarily and many of them to die as the result of its monopolistic practices, while public health programs face bankruptcy.

Gilead CEO John C. Martin took home a reported $19 million last year in compensation--the spoils of untrammeled greed.

Hepatitis C is a global public health crisis, called a "viral time bomb" by the World Health Organization. 150 million people or more worldwide are estimated to be living with the disease. Untreated Hepatitis C can progress to cirrhosis, liver failure, and liver cancer. Every year, at least 700,000 people die from these complications--although HCV can be easily cured with just 12 weeks of medicines being sold by Gilead.

TECHNIVIE in combination with ribavirin is the first drug that has demonstrated safety and efficacy to treat genotype 4 HCV infections without the need for co-administration of interferon, an FDA-approved drug also used to treat HCV infection.

TECHNIVIE is not recommended for use in patients with moderate hepatic impairment (Child-Pugh B) and is contraindicated in patients with severe hepatic impairment (Child-Pugh C).

The recommended dosage of TECHNIVIE in adults is two tablets taken orally once daily (in the morning) with a meal without regard to fat or calorie content. TECHNIVIE is intended to be used in combination with ribavirin for 12 weeks. TECHNIVIE administered without ribavirin for 12 weeks may be considered for treatment-naïve patients who cannot take or tolerate ribavirin.

TECHNIVIE is contraindicated:
In patients with severe hepatic impairment due to risk of potential toxicity.
With drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events.
With drugs that are moderate or strong inducers of CYP3A and may lead to reduced efficacy of

TECHNIVIE.
In patients with known hypersensitivity to ritonavir (e.g. toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome).

The safety and efficacy of TECHNIVIE with ribavirin were evaluated in a clinical trial of 135 participants with chronic HCV genotype 4 infections without cirrhosis who were either treatment-naïve (n=86) or did not achieve a virologic response with prior treatment with pegylated interferon/ribavirin (n=49). Previous exposure to HCV direct-acting antivirals was prohibited. Ninety-one participants received TECHNIVIE with ribavirin once daily for 12 weeks. Forty-four participants received TECHNIVIE once daily without ribavirin for 12 weeks.
Results showed that 100 percent of the participants who received TECHNIVIE with ribavirin achieved a sustained virologic response. Of those who received TECHNIVIE without ribavirin, 91 percent achieved sustained virologic response.

Safety information was available for 316 participants with HCV treated with the recommended dose of TECHNIVIE in combination with other anti-HCV drugs in clinical trials. The three drugs included in TECHNIVIE are also included in Viekira Pak, previously approved for the treatment of HCV genotype 1 infection. Additional safety information for those drugs was available from the Viekira Pak trials. The most common side effects of TECHNIVIE with ribavirin were fatigue, weakness (asthenia), nausea, insomnia, itching (pruritus) and other skin reactions. The majority of adverse reactions were mild in severity. None of the subjects who received TECHNIVIE with ribavirin experienced a serious adverse reaction. None of the subjects receiving TECHNIVIE with or without ribavirin discontinued treatment due to an adverse reaction.

TECHNIVIE labeling includes a WARNINGS and PRECAUTIONS that elevations of liver enzymes to greater than five times the upper limit of normal occurred in approximately one percent of clinical trial participants. The elevations occurred more frequently in females taking contraceptives containing ethinyl estradiol. Contraceptives containing ethinyl estradiol must be discontinued prior to starting TECHNIVIE. Hepatic laboratory testing should be performed during the first four weeks of starting treatment, and as clinically indicated thereafter.

If you are interested in receiving information about a broader range of FDA topics, consider subscribing to the FDA Patient Network News, a twice monthly newsletter containing FDA-related information on a variety of topics, including new product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment, and other information of interest to patients and patient advocates.

Medivir announces that Janssen submitted supplemental New Drug Application to U.S. FDA for OLYSIO® (simeprevir) in combination with sofosbuvir

July 24, 2015 02:30 ET | Source: Medivir AB

Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announces that
Janssen Products, LP (Janssen ), has submitted a supplemental New Drug
Application (sNDA) to the U.S. Food and Drug Administration (FDA) to update the
label for once-daily, all-oral OLYSIO® (simeprevir).
OLYSIO® is a hepatitis C virus NS3/4A protease inhibitor, currently approved in
the U.S. for use with sofosbuvir for adults with genotype 1 chronic hepatitis C
(CHC) infection as a 12-week treatment for patients without cirrhosis or a 24
-week treatment regimen for patients with cirrhosis. Sofosbuvir is a nucleotide
analogue NS5B polymerase inhibitor marketed by Gilead Sciences, Inc.
OLYSIO® was approved in November 2014 in combination with sofosbuvir based on
the phase II COSMOS clinical trial. This sNDA is based on results from the phase
III OPTIMIST-1 and OPTIMIST-2 trials, which evaluated 12 and eight weeks of
therapy for genotype 1 CHC adult patients without cirrhosis, and 12 weeks of
therapy for genotype 1 CHC adult patients with cirrhosis.
Results from the OPTIMIST trials were presented in April 2015 at The
International Liver Congress™ 2015 of the European Association for the Study of
the Liver (EASL) in Vienna.

Please visit www.jnj.com/releases for more information.

For further information, please contact:
Ola Burmark, CFO Medivir AB, mobile: +46 (0)725-480 580.
Medivir is required under the Securities Markets Act to make the information in
this press release public. The information was submitted for publication at 8.30
CET on 24 July 2015.
About Simeprevir (OLYSIO®)
Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen Sciences
Ireland UC and Medivir AB and indicated for the treatment of chronic hepatitis C
infection as a component of a combination antiviral treatment regimen.
Simeprevir efficacy has been established in HCV genotype 1 and HCV genotype 4
infected patients with compensated liver disease, including cirrhosis. Janssen
is responsible for the global clinical development of simeprevir and has
exclusive, worldwide marketing rights, except in the Nordic countries. Medivir
AB retains marketing rights for simeprevir in these countries under the
marketing authorization held by Janssen-Cilag International NV.

In November
2013, simeprevir was approved by the U.S. Food & Drug Administration and, in May
2014, it was granted marketing authorisation by the European Commission.
Subsequent marketing authorisations have followed in several other countries
around the world. Indications vary by market.
About Medivir
Medivir is a research based pharmaceutical company with a research focus on
infectious diseases and oncology. We have a leading competence within protease
inhibitor design and nucleotide/nucleoside science and we are dedicated to
develop innovative pharmaceuticals that meet great unmet medical need. Our
commercial organization provides a growing portfolio of specialty care
pharmaceuticals on the Nordic market. Medivir is listed on the Nasdaq Stockholm
Mid Cap List.

With the rise in heroin use we've recently reported on, infection control experts have another hidden health concern.

Stymied pill-users turning to cheaper, easier-to-get heroin
Chattanooga Times Free Press
Already, state officials have seen a rise in hepatitis C, Varney said. And the source of the drugs is more dangerous. Whereas about 70 percent of prescription drug abusers in Tennessee have gotten their pills from a family member, the heroin market is ...

Government audits just released as the result of a lawsuit detail widespread billing errors in private Medicare Advantage health plans going back years, including overpayments of thousands of dollars a year for some patients.

Updates Around The WebLiver disease in menopause
An editorial published in the July issue of "World Journey of Gastroenterology," reviewed the impact of menopause on the natural history of liver disease, including both hepatitis C and nonalcoholic fatty liver disease (NAFLD).

Data have clearly shown unique issues in the development and natural history of liver disease in menopause. As there is ongoing concern about the progression of liver injury with liver disease in the menopausal state, this also raises concern about the possible need for specialized approaches to liver disease management among women with chronic liver disease who are in menopause or approaching menopause. Previous therapy for HCV liver disease, namely pegylated interferon, carried a substantial side effect profile, and thus, recommendations often suggested consideration for use of pegylated interferon in the setting of patients with more advanced levels of fibrosis[53]. Historically, many HCV-infected patients waited until achieving this level of fibrosis before consideration for treatment. Concern regarding a more accelerated progression of fibrosis in postmenopausal women with HCV liver disease suggests a need for consideration for a more aggressive treatment approach in women, particularly among those who are peri-menopausal or in their younger years of menopause, so as to avoid accelerated progression toward advanced HCV liver disease. Presently, newer HCV treatments, including sofosbuvir, simeprevir, sofosbuvir/ledipasvir, and paritaprevir/ritonavir/ombitasvir/dasabuvir, have minimal side effect profiles, and thus, issues regarding timing of HCV treatment are no longer influenced by concerns about side effects. As these drugs are relatively new and markedly superior in the ability to eradicate HCV infection, there are no data regarding whether there is a reduced likelihood of response to treatment in menopause as has previously been demonstrated in interferon-based treatment. However, there should continue to be concern about ensuring that HCV infection is aggressively managed in all populations and particularly in women who are at risk for acceleration of the severity of HCV liver disease....

After each detailed case is discussed a list of multiple choice questions will appear, in order to move forward the question must be answered correctly, if you don't know the answer click on the "curbside consult" button located in the bottom corner of the presentation. Instructions will be explained after launching the program.

Cases 1-4 include HCV recurrence after liver transplantation, HCV/HIV co-infection, in addition an explanation of blood tests used in HCV is also featured.

dlDNA Marks Progression of HBV-Related Liver Disease
July 6 – The level of serum duplex-linear DNA (dlDNA) increases markedly with liver disease progression and the development of hepatocellular carcinoma in patients with chronic hepatitis B, suggests research published in Gut.

Addressing the Restricted Use of DAA therapies
Posted on July 6, 2015
Results of a new US cost effectiveness study indicate that effective direct acting antiviral (DAA) therapies should be not be restricted to only those HCV-infected patients with advanced fibrosis. Authors note that as a society, we have an opportunity to eliminate hepatitis C by taking appropriate and timely steps, and we should be willing to pay for the current HCV therapies by providing additional resources and giving hepatitis C the attention it deserves.

Last year I wrote a post of “5 Key Things to Know About Meta-Analysis”. It was a great way to focus – but it was hard keeping to only 5. With meta-analyses booming, including many that are poorly done or misinterpreted, it’s definitely time for a sequel!

Meta-analysis is combining and analyzing data from more than one study at a time. Using a variety of statistical methods, some of which were purpose-built, you can condense a vast amount of information into a single summary statistic.

1. A meta-analysis is a safer starting point than a single study – but it won’t necessarily be more reliable.

A meta-analysis is usually part of a systematic review. It’s a heavy-duty effort, and it’s often described as the ultimate study, outweighing all others. The last word. A single study becomes a puny thing, to be ignored even....

Hep Forums, is a round-the-clock discussion area for people who have Hepatitis B, C or a co-infection, their friends and family and others with questions about hepatitis and liver health. Check in frequently to read what others have to say, post your comments, and hopefully learn more about how you can reach your own health goals.

A recent article appeared in Gastroenterology that provided an overview of herbal products. This review will focus on the important issues regarding the lack of standardization, possible contamination, some deceptive claims and a list of the herbs that have the most potential to harm the liver.Read more...

HealthWise: Hepatitis C and Pain—Part 2
Lucinda K. Porter, RN

Part 2 of a two-part series discussing pain associated with hepatitis C, focusing on pain management techniques that have little or no risk of injuring the liver.Read more...

Alan Franciscus, Editor-in-Chief
Read about long term treatment outcomes and the benefits of achieving an SVR, and a study on methadone continuation vs. forced withdrawal in a Rhode Island prison and jail.Read more...

A New Powerful HCV Health Tool
Alan Franciscus, Editor-in-Chief
In this age of technology, hepatitis C finally has it is own App! This technology is brought to you by Help-4-Hep which provides peer-to-peer counselling services for people with hepatitis C. It is available on the internet and mobile devices.Read more...

The primary goal of the Caring Ambassadors Program is to help individuals with challenging health conditions to become ambassadors for their own health. We are here to help you—that is now and always will be our singular focus.

Weekly News
Weekly news updates are currently posted on the Internet site and sent out via e-blast to provide up-to-date information on what has been covered in the news regarding hepatitis C in the previous week. Topics include all stories related to hepatitis C as well as personal stories and events.

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Liver Lowdown is the monthly general interest e-newsletter of the American Liver Foundation.

In accordance with the Foundation’s mission, the e-newsletter is disseminated to provide information about the prevention, treatment and cure of liver disease, as well as the organization’s research and advocacy endeavors.

Liver Lowdown content includes updates about the Foundation’s educational and signature programs; an in-depth focus on specific types of liver disease, and profiles of liver patients’ and caregivers’ personal experiences.

GI & Hepatology News
GI & Hepatology News is the official newspaper of the AGA Institute and provides the gastroenterologist with timely and relevant news and commentary about clinical developments and about the impact of health-care policy. The newspaper is led by an internationally renowned board of editors.

HepCBC Hepatitis C Education and Prevention SocietyHepCBC’s MONTHLY NEWSLETTER
The hepc.bull, has been “Canada’s hepatitis C journal” since the late 1990′s and has been published nonstop since 2001. The monthly newsletter contains the latest research results, government policy changes, activities and campaigns you can get involved in, articles by patients and caregivers, and a list of support groups plus other useful links.

NYC Hep C Task Force
The
New York City Hepatitis C Task Force is a city-wide network of service
providers and advocates concerned with hepatitis C and related issues.
The groups come together to learn, share information and resources,
network, and identify hepatitis C related needs in the community.
Committees form to work on projects in order to meet needs identified by
the community

NewsLouis Jones: HIV undetectable, Hep C cured!
July 9, 2015
Louis Jones is a peer navigator at Harlem United FROSTD and he participated in the IDUHA Hep C Peer Navigation Program. His story is one of resilience, advocacy and attaining a goal he never imagined possible: being cured of Hep C. Louis started using heroin when he was 19 years old, and in 1986 he …

Prescribe opioids, but with caution
By Ryan DuBosar
Use of opioids for chronic pain quadrupled in a 10-year span, despite scant evidence that they are effective for noncancer pain and ample evidence of harm. Learn more about how to prescribe them safely.MORE

Women's health
SSRIs may be associated with increased fracture risk in middle-aged women without mental disorders

Women without mental illness who started SSRIs and a cohort of women who started H2 antagonists or proton-pump inhibitors (without SSRIs) were compared, with a main study outcome of hip, humerus, radius, or ulna fractures 1 or more days after starting therapy.

Tuesday, July 7, 2015

New Treatment Cures Hepatitis CPills Are ‘Revolutionary,’ Liver Expert SaysBy Lori Newman, Special to Lifescript Published July 07, 2015

Reviewed by Edward C. Geehr, M.D., Lifescript Chief Medical Officer

The future is much brighter for people with a hepatitis C diagnosis, thanks to breakthroughs in the treatment of the deadly viral liver infection.

“The treatments we [have now] are revolutionary in terms of tolerability and ability to get over 90% of patients cured,” says Tram T. Tran, M.D., medical director of liver transplantation at the Liver Disease and Transplant Center at Cedars-Sinai Medical Center in Los Angeles.

HCV Education
Review learning activities, editorials, with new data about interferon-free regimens approved for HCV, as well as investigational drugs still in the pipeline. Links are provided to support, patient friendly information, clinical trials, peer-reviewed journals, videos, conferences with commentary, all updated on a continuous basis.

Users can search for a hepatitis C clinical trial by category (genotype), or learn how to evaluate a clinical trial and become familiar with commonly used terms. HCV Advocate offers an easy to navigate HCV Medications Blog as well, organized by HCV genotype

View each rebuttal and all ongoing media coverage. In June the HCV community was blindsided when an article with a somewhat "clickbait" headline was released by The Guardian. The Guardian reported on a systematic review published by the Cochrane Collaboration that suggested achieving SVR (cure) for patients using hepatitis C direct-acting antivirals (DAAs) doesn't correlate with any long term benefits.

The controversy over expensive new drugs for hepatitis C
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"

Liver Cancer After Treatment For Hepatitis C
​Research demonstrates that while SVR markedly reduced liver-related complications and liver cancer, some long-term risk for liver cancer remained in those who were cured of Hepatitis C. But after direct-acting antiviral therapy does the risk of developing liver cancer increase?

Meeting Updates

April 19-23
The European Association for the Study of the Liver (EASL) International Liver Congress (ILC 2017)

Merck today announced its strategic decision to discontinue the development of the investigational combination regimens MK-3682B (grazoprevir/ruzasvir/ uprifosbuvir) and MK-3682C (ruzasvir/uprifosbuvir) for the treatment of chronic hepatitis C virus (HCV) infection. This decision was made based on a review of available Phase 2 efficacy data and in consideration of the evolving marketplace and the growing number of treatment options available for patients with chronic HCV infection

Two HCV Drugs to Be Discontinued
The Food and Drug Administration (FDA) announced that Rebetol(ribavirin; Merck) capsules and PegIntron (peginterferon alfa-2b; Merck) for Injection are being discontinued. The decision is business-related and not due to safety or efficacy issues with the drugs.

Rebetol is a nucleoside analogue indicated for chronic hepatitis C in combination with interferon alfa-2b (pegylated and nonpegylated), in patients ≥3 years of age with compensated liver disease. It is supplied as 200mg capsules in 56-, 70-, and 84-count bottles. The Rebetol discontinuation is effective February 1, 2016.
PegIntron is an antiviral indicated for treatment of chronic hepatitis C in patients with compensated liver disease. It is supplied as 50mcg/0.5mL, 80mcg/0.5mL, 120mcg/0.5mL, and 150mcg/0.5mL single-use vials and single-use pre-filled pens. No effective date is available for the PegIntron discontinuation.

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It is believed that this use constitutes a 'fair use' of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, the material on this site is distributed to visitors of this “HCV New Drugs Blog” without profit to the blog or to those who by visiting this blog have expressed interest in receiving the included information for research and educational purposes.

The material in this site is provided for educational and informational purposes only, and is not intended to be a substitute for a health care provider's consultation. Please consult your own appropriate health care provider about the applicability of any opinions or recommendations with respect to your own symptoms or medical conditions. The information on this site does not constitute legal or technical advice